Reata Presents Promising Data on Bardoxolone at American Diabetes Association Annual Scientific Meeting

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The final data from the stud demonstrated that patients treated with bardoxolon e experienced a greater than 20 percentincreasr (p<0.0001) over baseline in theirt estimated glomerular filtration rate (GFR), a measure of the kidney's filtration capacity and the primaryh endpoint of the study. CKD is a progressivd and incurable disease, and currently approved treatments only modestl y reduce the rate of decline inthe kidney's GFR over In the bardoxolone CKD study, approximately 90 percent of patients on drug experienced an increase in their GFR, and patientsd with more severe stagwe 4 CKD at baseline experienced an even greaterf (36 percent) increase in GFR (p<0.0001).
Based on the resultsx of this Phase IIclinical trial, Reatwa has initiated a longer term, late stage trial of bardoxolonwe in patients with diabetes and advancee CKD. Bardoxolone and other AIMs activate Nrf2 a transcription factorror "master gene" which controls the production of over 250 antioxidant and detoxification proteins. Activatiob of Nrf2 promotes the resolution of chronif inflammation by interrupting reactive oxygendriven pro-inflammatoryy signaling.
The hyperglycemia experienced by diabetics causex excessive production of reactive oxygen in the kidneyand vasculature, and the resulting chronic inflammatiom is believed to be a significant causse of diabetic complications such as CKD and cardiovascularr disease. Lead investigator and studyy presenter Dr. commented, "Thise study of bardoxolone is very encouraging. These results suggest for the firsg time that diabetic patients with kidney disease may be able to regainj some kidney function and perhaps stop the progression toware end stage renal diseaseand dialysis. " Dr.
Schwartz is the Vice President of Scientific Affaira of dgd Research and Medical Director of theDiabeteds & Glandular Disease Clinic in San Antonio, Texas. Study Patient Population, and Results The bardoxolone CKD study wasan randomized, dose-ranging study designed to test the efficacy of bardoxolone in diabetivc patients with stage 3 or 4 CKD. Sixty patiente were randomized toreceive 25, 75 or 150 mg per day of bardoxolones in addition to standarxd therapy for 28 days. The primary endpoin for the study was a change from baseline inestimatee GFR. The study also assessed the drug'xs impact on measures of glycemic contro andcardiovascular disease.
The trial enrolled patient s witha long-term history of diabetes (averagee of 19 years) and significant diabetidc complications including CKD. All patients had significanyt renal impairmentat baseline, with a mean GFR of 36 ml/min/1.73 meterxs squared, representing a loss of almosty two thirds of kidney function compared with a healthy adult. Over one-third of subject s had severe or stage4 CKD, with a GFR of less than 30 ml/min/1.7w meters squared. These patients woulxd be expected to progress to end stage rena ldisease (and require dialysise or a kidney transplant) withihn one to three yearsa with currently available treatments. Patients treated with bardoxolonwe experienceda 20.
5 percent mean increase in estimated GFR over baselinee (p<0.0001). Patients with stagd 4 CKD at baseline experienced a 36 percent mean increases in estimated GFR overbaseline (p<0.0001). The renakl function improvements were highly consistent with approximately 90 percenyt of patients experiencing an increasew in estimated GFR from baseline duringthe study. Significanty improvements were also seen in otheer markers of renalfunction (creatinine clearance, blood urea phosphorus, and uric acid), glycemic control (glycosylateds hemoglobin A1C and fasting plasma glucose), and cardiovascularf disease (circulating endothelial angiotensin II, and adiponectin).
Basedc on the results of this Phase II clinical as well as two previouws trials demonstrating similar effects in otherpatient populations, Reatq has initiated a larger, longer-term study of bardoxolone in diabetixc patients with CKD. This Phase IIb study will enroll a totao of 200 patients to be treatedd forone year. Results will be available durin 2010. Results for the primary and related renaol function endpoints from the phase II clinical triall evaluating bardoxolone in diabetic patients with advanced CKD will be the subject of an oral presentationat 4:00 PM CDT on June 6, 2009. , , D.O., , M.D., , M.D., , M.D.
, Location: Morial Convention Center, New LA, Room Louisiane C Abstract No. 112-OR Results for the glycemicx control endpoints from the phase II clinica l trial evaluating bardoxolone in diabetic patientzs with advanced CKD will be the subjectr of an oral presentationat 5:15 PM CDT on June 8, 2009. Bardoxolone, a Novel Oral Anti-Inflammatory Agent Improves Glycemic Control in Type 2 Diabetics with Chronic KidneDisease , M.D., , D.O., , M.D., , , M.D., Ph.D. Location: Morial Convention New Orleans, LA, Hall E-2 Abstract No.
362-OR CKD is a progressived loss of kidney function over a period of months or which can be caused by a numbe rof conditions, including diabetews and high blood pressure. As kidney diseasr gets worse, waste products can build to high level s in the blood and patients may develop complicationsd like highblood pressure, anemia (low blooc count), weak bones, poor nutritional health and nerve damage. CKD also increasezs the risk of having heart and blooedvessel disease. As kidney disease progresses, it eventually leads to kidnegy failure, requiring dialysis or a kidney transplant. Reatq Pharmaceuticals, Inc.
is a biopharmaceutical company focused on translating innovative science into breakthrough medicinesz forintractable diseases. Reata is the leader in discoveringt and developingnovel anti-inflammatory drugs targeting which controls the production of antioxidante and has been shown to protect againsyt a broad range of diseases associatecd with inflammation and oxidative Reata is developing a portfolio of AIMs for a variety of inflammation-relate diseases. The company's most advanced program is in late-stage clinical developmen t for CKD, a progressive condition affecting more than 26millio Americans. For more information, visir . SOURCE Reata Pharmaceuticals, Inc.